Associate Director, QA Biologics Development
Other Locations:US- NJ- Summit West
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Scope: The Position provides Quality oversight for New Development Compounds for both Bulk Drug Substance and Drug Product, including but not limited to their batch disposition related activities. The incumbent will cover multiple CMC Compound Development teams for Biologics and will report to the Director Development QA, Biologics, Global Quality Assurance.
Responsibilities include, but are not limited to, the following:
- Member of CMC Development Teams providing Quality input from Phase 1 through late Development and Product commercialization.
- Partners with Technical Operations and Pharmaceutical Development to develop and implement the Pharmaceutical Development strategy for new drug candidates Partners with Technical Operations and Pharmaceutical Development to identify and qualify manufacturing facilities for the Development, Manufacture, Testing and Packaging of Clinical product (Bulk Drug Substance and Drug Product), and ensures Quality Agreements are in place for Clinical Supply. Key member of the Quality Audit Team/partners with GMP Compliance Audit.
- Responsible for product change management through the development process to include impact assessments, tracking and implementation to ensure a compliant fileable product and process is developed.
- Track/Own ongoing regulatory updates to Health Authorities (e.g. IND/BLA) from a quality perspective including specifications, shelf life extensions, country specific trial approvals etc.
- Works with CMC Teams to conduct risk assessments for all aspects of the Development Process and Supply chain.
- Final Quality approver for all GMP documentation associated with the Development and Validation of the Product to include Manufacturing and Testing Methods, Specifications, Stability Protocol and Reports, and Validation Protocols and Reports.
- Responsible for Quality input for CMC sections of the IND/BLA and the final Quality Review prior to filing.
- Provides Quality oversight for all key Quality Systems associated with the development drug candidate including Complaints, Recalls, Field Alerts, Deviations, CAPA, etc.
- Performs other tasks as assigned
- Thorough knowledge of the Pharmaceutical Development Process as evidenced by bringing multiple INDs through to successful BLA approval.
- Knowledge of bulk biologic drug substance (monoclonal antibody, etc.) and Parenterals (cold chain liquid/lyophilized form) would be considered an advantage.
- Strong working knowledge of the cGMPs as it applies to the quality area in Biologics Pharmaceutical Development.
- Understanding of Health Authority expectations relative to CMC Development as well as Clinical Trial supplies.
- Track record of successful Pre Approval Inspections.
- Extensive experience in the quality management of outsourced operations (i.e. contract manufacturing organizations).
- Good Knowledge of CMC Regulatory Affairs for development.
- Recognized as a CMC Biologics expert with an ability to introduce best practices into the quality management systems.
- Demonstrates ability to resolve complex problems where analysis of complex data and in-depth evaluation of various factors is required.
- Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
Ten years of hands on CMC experience within a biotherapeutics development/ GMP operations facility, including 5 years plus in QA for Biologics.
- An equivalent combination of education and experience may substitute
#LI-POSTCelgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.